# CG Bio Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For CG Bio Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF), import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is KOREA (THE REPUBLIC OF); product is MAYFILL Deep Cross-linked Hyaluronic Acid | MAYFILL Volume Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | MAYFILL Deep Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | MAYFILL Volume Cross-linked Hyaluronic Acid; product code is 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 01/13/2025; address is 29 Jeyakdanji-Ro , Hyangnam-Eup , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** CG Bio Co., Ltd. _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 29 Jeyakdanji-Ro , Hyangnam-Eup , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 01/13/2025 _(verified: appears in the quote below)_
- **Product code:** 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular _(verified: each item appears in the quote below)_
- **Product:** MAYFILL Deep Cross-linked Hyaluronic Acid | MAYFILL Volume Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | MAYFILL Deep Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | MAYFILL Volume Cross-linked Hyaluronic Acid _(verified: each item appears in the quote below)_

## What the source says

> CG Bio Co., Ltd. Date Published : 01/13/2025 29 Jeyakdanji-Ro , Hyangnam-Eup , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF) 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 01/13/2025 Desc: MAYFILL Deep Cross-linked Hyaluronic Acid 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 01/13/2025 Desc: MAYFILL Volume Cross-linked Hyaluronic Acid 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 01/13/2025 Desc: Cross-linked Hyaluronic Acid 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 01/13/2025 Desc: MAYFILL Deep Cross-linked Hyaluronic Acid 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 01/13/2025 Desc: Cross-linked Hyaluronic Acid 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 01/13/2025 Desc: MAYFILL Volume Cross-linked Hyaluronic Acid

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).